Efficacy, Safety, and Tolerability of 4-MUST Tablets in Chronic Cholecystitis and Biliary Dyskinesia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorValenta Pharm JSC
About this trial
This study aims to evaluate the efficacy, safety, and tolerability of the drug 4-MUST at various doses compared to placebo in patients with chronic cholecystitis and biliary dyskinesia
Eligibility criteria
Qualifiers
Males and females aged 18-70 years.
Presence of established gastrointestinal diseases: Chronic cholecystitis (K81.1); Dyskinesia of the bile duct or gallbladder (K82.8).
Presence of pain/discomfort in the upper abdomen combined with at least one of the following symptoms: Heartburn; Belching; Nausea; Abdominal bloating; Borborygmi (stomach rumbling); Flatulence; Constipation; Diarrhea.
Maximum severity of pain/discomfort in the upper abdomen over the past week is 40 mm or more on the VAS (Visual Analog Scale).
Disqualifiers
Incorrect enrollment of a patient in the study (failure to meet inclusion/exclusion criteria at the time of randomization).
Ineffectiveness of therapy. The therapy will be deemed ineffective if there is no clinical improvement by visit 3 (15±1 days of therapy) - persistence or increase in the severity of pain/discomfort in the upper abdomen on the VAS compared to baseline. If excluded, the patient will be assigned alternative treatment at the discretion of the investigator.
Patient non-compliance (a compliant patient is defined as one who has taken at least 202 and no more than 303 tablets).
Requirement for prohibited concomitant therapy.
Trial design
Treatments tested in this trial
- 4-MUST
- Placebo
Treatment groups
300 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov